Effect of a Self-Efficacy-Based Educational Intervention on Breastfeending in Primigravid Women: A Randomized Controlled Trial

NCT07593716 | Not Yet Recruiting

• 2 other identifiers: IMSS-UMF-BSES-2026R-2026-1101-006
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effect of a self-efficacy-based educational intervention on exclusive breastfeeding among primigravid women attending a primary care center in Mexico. Participants in the intervention group will receive four weekly educational sessions focused on breastfeeding knowledge, self-efficacy, problem-solving skills, and emotional support during the third trimester of pregnancy. The control group will receive standard prenatal care. Breastfeeding self-efficacy and exclusive breastfeeding rates will be evaluated during postpartum follow-up at 1 and 3 months after delivery.

Conditions

Exclusive Breastfeeding; Breastfeeding Self-Efficacy; Pregnancy; Maternal Health Education

Keywords

Breastfeeding; Primigravid Women; Educational Intervention; Randomized Controlled Trial; BSES-SF; Primary Care; Mexico

Outcome Measures

Primary Outcomes (1)

• Exclusive Breastfeeding Rate at 3 Months Postpartum

  Proportion of mothers who maintain exclusive breastfeeding at 3 months postpartum after receiving an educational intervention based on breastfeeding self-efficacy.

  3 months postpartum

Study Arms (2)

Educational Intervention Group

EXPERIMENTAL

Participants will receive a breastfeeding educational intervention based on self-efficacy theory during the third trimester of pregnancy. The intervention includes four weekly sessions focused on breastfeeding knowledge, techniques, confidence building, and problem-solving strategies.

Behavioral: Breastfeeding Self-Efficacy Educational Program

Control Group

NO INTERVENTION

Participants will receive standard prenatal care routinely provided at the family medicine unit without the additional breastfeeding educational intervention.

Interventions

Breastfeeding Self-Efficacy Educational Program BEHAVIORAL

Participants will receive four weekly educational sessions during the third trimester of pregnancy based on breastfeeding self-efficacy theory. Sessions will include breastfeeding education, practical techniques, confidence building, problem-solving strategies, and support to improve exclusive breastfeeding practices postpartum.

Educational Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18 years or older
• Primigravidae in the third trimester of pregnancy
• Receiving prenatal care at UMF No. 9, IMSS
• Ability to attend the educational sessions
• Willingness to participate and sign informed consent

You may not qualify if:

• High-risk pregnancy
• Medical conditions contraindicating breastfeeding
• Cognitive impairment or communication difficulties preventing participation
• Previous participation in breastfeeding educational programs
• Failure to complete follow-up evaluations

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Tropical Disease Research Centre: collaborator

Study Sites (1)

Unidad de Medicina Familiar No. 9

Acapulco de Juárez, Guerrero, 39300, Mexico

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Guadalupe Aguilar Hernández, MD

  INSTITUTO MEXICANO DEL SEGURO SOCIAL, UNIDAD DE MEDICINA FAMILIAR NO. 9

  PRINCIPAL INVESTIGATOR

• Sergio Paredes Solis, MD

  Centro de Investigación de Enfermedades Tropicales, Universidad Autonoma de Guerrero

  STUDY DIRECTOR

Central Study Contacts

Guadalupe Aguilar Hernández, MD

CONTACT

+527442298212; guadalupe.aguilarhe@imss.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Medicine Specialist

Model Details: Participants will be randomly assigned to either an educational intervention group based on breastfeeding self-efficacy or a control group receiving standard prenatal care. Both groups will be followed during pregnancy and evaluated at 1 and 3 months postpartum.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)